[Federal Register: July 29, 2004 (Volume 69, Number 145)]
[Notices]
[Page 45336-45337]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy04-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0558]
Compliance Policy Guide, Guidance Levels for Radionuclides in
Domestic and Imported Foods, Availability; and Supporting Document,
Supporting Document for Guidance Levels for Radionuclides in Domestic
and Imported Foods, Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a compliance policy guide (CPG) entitled ``Guidance
Levels for Radionuclides in Domestic and Imported Foods.'' This
document is intended to make FDA offices and the industry aware of
FDA's guidance for enforcement concerning radionuclide activity
concentration in domestic food in interstate commerce or food offered
for import. This CPG rescinds and replaces CPG Sec. 560.750
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14). The
agency also is announcing the availability of a final supporting
document entitled ``Supporting Document for Guidance Levels for
Radionuclides in Domestic and Imported Foods.''
DATES: Submit written or electronic comments concerning the CPG or the
final supporting document at any time.
ADDRESSES: Submit written requests for single copies of the CPG
entitled ``Guidance Levels for Radionuclides in Domestic and Imported
Foods'' and/or the final supporting document entitled ``Supporting
Document for Guidance Levels for Radionuclides in Domestic and Imported
Foods'' to Paul South (see FOR FURTHER INFORMATION CONTACT). Send two
self-addressed adhesive labels to assist that office in processing your
request. Submit written comments to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for
electronic access to these documents.
FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety and
Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1640.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 14, 2004 (69 FR 2146), FDA
announced the availability of a draft CPG entitled ``Guidance Levels
for Radionuclides in Domestic and Imported Foods,'' and a draft
supporting document entitled ``Supporting Document for Guidance Levels
for Radionuclides in Domestic and Imported Foods.'' After considering
comments received on these documents, FDA has finalized the CPG and
supporting document. The CPG rescinds and replaces CPG Sec. 560.750
Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14).
FDA received five comments on the draft CPG. The comments
represented the views of individual consumers, a Federal agency, a
State health department, and a foreign government. One comment was
rejected because it was outside the scope of the draft CPG. The
majority of comments supported the proposed guidance levels while a
number of comments suggested changes or modification to other aspects
of the draft CPG. After considering carefully the comments received,
the agency revised the draft CPG to include a reference to methods for
radionuclide analysis of foods.
The CPG is being issued as level 1 guidance consistent with FDA's
good
[[Page 45337]]
guidance practices regulation (21 CFR 10.115). The CPG represents the
agency's current thinking on its enforcement process concerning the
adulteration of food with radionuclides. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the CPG
entitled ``Guidance Levels for Radionuclides in Domestic and Imported
Foods,'' and/or the final supporting document entitled ``Supporting
Document for Guidance Levels for Radionuclides in Domestic and Imported
Foods.'' Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in the brackets in the heading of this document. A copy of the CPG, the
final supporting document, and received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the CPG and final
supporting document may be accessed from the home pages of the Center
for Food Safety and Applied Nutrition at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov and the Office of Regulatory Affairs at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/.
Dated: July 22, 2004.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-17208 Filed 7-28-04; 8:45 am]
BILLING CODE 4160-01-S